Abbott (ABT) Offers Results of Studies Evaluating LCIG, Says Safety Endpoint Showed AE Mild to Moderate
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Abbott (NYSE: ABT) announced results from five abstracts evaluating levodopa-carbidopa intestinal gel (LCIG), its investigational compound for advanced Parkinson's disease. The abstracts include the results from the second interim analysis of a long-term safety and tolerability trial, as well as secondary endpoint analyses from the Phase 3 pivotal trial. All of the abstracts were presented at The 16th International Congress of Parkinson's Disease and Movement Disorders, June 17-21 in Dublin, Ireland.
In a 54 week open-label safety and tolerability study of 354 patients with advanced Parkinson's disease, the primary endpoint of safety showed adverse events (AEs) were mostly mild to moderate, were generally associated with the Percutaneous Endoscopic Gastrostomy (PEG) tube placement procedure and its complications, were transient, and resolved over time.
In the secondary endpoint analysis from the open-label study, patients experienced an average daily "off" time of 6.7 hours, and 7.7 hours of "on" time without troublesome dyskinesia at baseline. "Off" time refers to periods of poor mobility, slowness and stiffness experienced by patients with Parkinson's disease, while "on" time refers to periods of good motor symptom control. At week 54, mean daily "off" time had decreased an average of 4.5 hours, and "on" time without troublesome dyskinesia had increased by 5.1 hours. "On" time with troublesome dyskinesia decreased an average of 0.6 hours.
The most common treatment emergent AEs were complication of device insertion (33.1 percent), abdominal pain (30.0 percent), procedural pain (21.7 percent) and nausea (16.1 percent). The most common serious treatment emergent AEs were complication of device insertion (6.5 percent), abdominal pain (3.1 percent) peritonitis (2.8 percent) and polyneuropathy (2.8 percent). Twenty-six patients (7.3 percent) withdrew due to at least one AE; 17 of these patients withdrew due to at least one serious AE. Gastrointestinal- and PEG-related issues were the most common cause of withdrawal from the study.
Phase 3 EfficacyFunctional and quality of life secondary endpoint analyses from a twelve-week double-blind, double-dummy pivotal trial of 71 patients comparing LCIG to standard levodopa-carbidopa immediate release (LC-IR) tablets were also presented. The primary endpoint of this study showed a reduction in mean daily "off" time of 4.0 hours, a statistically significant difference of 1.91 fewer hours spent in "off" time with LCIG compared to LC-IR tablets. These data were previously presented at the American Academy of Neurology Annual Meeting (April 21-28, 2012, New Orleans, Louisiana). The most common adverse events were complication of device insertion (51 percent), abdominal pain (42 percent), procedural pain (32 percent), nausea (25 percent), constipation (21 percent), orthostatic hypotension (18 percent), post-operative wound infection (17 percent), and incision site erythema (16 percent).
In a 54 week open-label safety and tolerability study of 354 patients with advanced Parkinson's disease, the primary endpoint of safety showed adverse events (AEs) were mostly mild to moderate, were generally associated with the Percutaneous Endoscopic Gastrostomy (PEG) tube placement procedure and its complications, were transient, and resolved over time.
In the secondary endpoint analysis from the open-label study, patients experienced an average daily "off" time of 6.7 hours, and 7.7 hours of "on" time without troublesome dyskinesia at baseline. "Off" time refers to periods of poor mobility, slowness and stiffness experienced by patients with Parkinson's disease, while "on" time refers to periods of good motor symptom control. At week 54, mean daily "off" time had decreased an average of 4.5 hours, and "on" time without troublesome dyskinesia had increased by 5.1 hours. "On" time with troublesome dyskinesia decreased an average of 0.6 hours.
The most common treatment emergent AEs were complication of device insertion (33.1 percent), abdominal pain (30.0 percent), procedural pain (21.7 percent) and nausea (16.1 percent). The most common serious treatment emergent AEs were complication of device insertion (6.5 percent), abdominal pain (3.1 percent) peritonitis (2.8 percent) and polyneuropathy (2.8 percent). Twenty-six patients (7.3 percent) withdrew due to at least one AE; 17 of these patients withdrew due to at least one serious AE. Gastrointestinal- and PEG-related issues were the most common cause of withdrawal from the study.
Phase 3 EfficacyFunctional and quality of life secondary endpoint analyses from a twelve-week double-blind, double-dummy pivotal trial of 71 patients comparing LCIG to standard levodopa-carbidopa immediate release (LC-IR) tablets were also presented. The primary endpoint of this study showed a reduction in mean daily "off" time of 4.0 hours, a statistically significant difference of 1.91 fewer hours spent in "off" time with LCIG compared to LC-IR tablets. These data were previously presented at the American Academy of Neurology Annual Meeting (April 21-28, 2012, New Orleans, Louisiana). The most common adverse events were complication of device insertion (51 percent), abdominal pain (42 percent), procedural pain (32 percent), nausea (25 percent), constipation (21 percent), orthostatic hypotension (18 percent), post-operative wound infection (17 percent), and incision site erythema (16 percent).
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